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Browse Drug Recalls

942 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 942 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 942 FDA drug recalls in TX.

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DateProductReasonClassFirm
Oct 5, 2020 MORPHINE-BUPIVACAINE PF INJECTABLE 21 mL, 22 mL, 23 mL, 41 mL and 43 mL syrin... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 FENTANYL-BUPIVACAINE HCL PF INJECTABLE 3000MCG-12MG/ML, 21 mL syringe, Rx onl... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 HYDROMORPHONE HCL-BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 21 mL syringes in v... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 MORPHINE-HYDROMORPHONE-BUPIVACAINE PF 13MG-19MG-2MG/ML INJECTABLE 21 mL syrin... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 HYDROMORPHONE HCL-BUPIVACAINE HCL-FENTANYL PF INJECTABLE 21 mL syringe in var... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 HYDROMORPHONE HCL-BUPIVACAINE HCL-CLONIDINE HCL PF INJECTABLE 21 mL syringes ... Non-Sterility Class I Med Shop Total Care Inc.
Oct 5, 2020 BUPIVACAINE HCL-BACLOFEN PF INJECTABLE 40MG-4000MCG/ML, 21 mL syringe, Rx onl... Non-Sterility Class I Med Shop Total Care Inc.
Sep 24, 2020 SYP Health Hand Sanitizer Alcohol Gel (ethyl alcohol) 70%, Net Wt. 16.91 FL O... CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled... Class II AA PRODUCTS INC
Sep 9, 2020 M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,7... Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and bel... Class I MEDEK LLC
Sep 1, 2020 Red-E Tablet, Proprietary Blend 3000 mg**, packaged in 1-count plastic bag st... Marketed Without An Approved NDA/ANDA: product found to be tainted with sildenafil, an FDA approv... Class I The Protein Shoppe
Aug 7, 2020 UltraCruz Hand Sanitizing Gel Antimicrobial (70% Isopropyl Alcohol), packaged... Subpotent drug Class II Santa Cruz Biotechnology, Inc
Aug 4, 2020 Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL ... cGMP Deviations. Class II Eosera, Inc.
Aug 4, 2020 Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%... cGMP Deviations. Class II Eosera, Inc.
Aug 4, 2020 Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (1... cGMP Deviations. Class II Eosera, Inc.
Aug 4, 2020 Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eos... cGMP Deviations. Class II Eosera, Inc.
Jul 11, 2020 blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) P... Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... Class I 4e Brands North America, Llc
Jul 11, 2020 blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost ... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 11, 2020 blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 11, 2020 blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost ... Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... Class I 4e Brands North America, Llc
Jul 11, 2020 blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v... Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... Class I 4e Brands North America, Llc
Jul 11, 2020 blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), pac... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 11, 2020 ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Pack... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 11, 2020 blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 11, 2020 ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packa... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 11, 2020 Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcoh... CGMP Deviations: recalled because it was manufactured in the same facility as the product found t... Class II 4e Brands North America, Llc
Jul 7, 2020 ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV reg... Class I CareFusion 213, LLC
Jul 7, 2020 BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the la... Class I CareFusion 213, LLC
Jul 7, 2020 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the la... Class I CareFusion 213, LLC
Jul 7, 2020 ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV reg... Class I CareFusion 213, LLC
Jun 29, 2020 Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antisepti... Chemical Contamination: Presence of Undeclared Methanol Class I Transliquid Technologies, LLC
Jun 23, 2020 ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides Class I CareFusion 213, LLC
Jun 23, 2020 BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) an... Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides Class I CareFusion 213, LLC
Jun 23, 2020 ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides Class I CareFusion 213, LLC
May 28, 2020 oxyTOCIN 30 Units/500 mL (0.06 Units/mL) added to 0.9% Sodium Chloride Inject... Subpotent drug - Product did not contain drug. Class II QuVa Pharma, Inc.
Apr 23, 2020 R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride ... Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac Class III QuVa Pharma, Inc.
Mar 16, 2020 Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement ... Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tada... Class I Y-O Management LLC, dba Natural Remedy Store
Dec 20, 2019 BAC 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML ML INJ in 20 mL syringe Assuran... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion (713... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HYDROMORPHONE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 53... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HYDROMORPHONE 3MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Inf... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 35MG/FENT 1.5MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML in 20 mL syringe Assurance Infusi... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 SUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion (713)-533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713)... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 3MG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713)... Lack of sterility assurance. Class II Assurance Infusion

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.